FDA Inspection 819660 — PharMEDium Services LLC
The FDA completed an inspection of PharMEDium Services LLC on February 28, 2013 in Dayton, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 28, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dayton, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1846 | 21 CFR 211.84(d)(3) | Establish reliability of supplier's C of A |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |
| 4320 | 21 CFR 211.84(d)(6) | Microbiological Contamination Exam |
| 4360 | 21 CFR 211.170(b) | Reserve drug product sample quantity - all tests |
| 4382 | 21 CFR 211.198(b)(2) | Written record of complaint to include findings, follow-up |